Axillary HyperhidrosisPhase 3CARDIGANIINCT03948646
Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302)
A Phase 3 study testing Sofpironium Bromide, 15% in people with Axillary Hyperhidrosis, run by Botanix Pharmaceuticals at 42 sites in United States.
Trial summary
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Read more about this study
- Who is it for?
- Ages 9 years and older
- Conditions the study is for
- Axillary Hyperhidrosis
- What is being tested?
- Sofpironium Bromide, 15%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 351 participants
- Where
- 42 sitesUnited States
- Study dates
- 4 Dec 2020to 13 Aug 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female subject ≥ 9 years of age.
- Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhidrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4 and (c) a minimum GSP of 50 mg in each axilla with a combined total of at least 150 mg.
- The ability to understand and follow all study-related procedures including study drug administration.
- Sexually active female of childbearing potential (FOCBP)* must agree to periodic pregnancy testing and use a medically acceptable method of contraception while receiving protocol-assigned product.
Who cannot join
- In the Investigators opinion, any skin or subcutaneous tissue conditions of the axilla(e).
- Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis.
- Anticholinergic agents used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration.
- Use of any cholinergic drug (e.g. bethanechol) within 28 days.
- Known cause of hyperhidrosis or known history of a condition that may cause hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism, diabetes mellitus, medications, etc.).
- Subjects with unstable diabetes mellitus or thyroid disease, history of renal or hepatic impairment, malignancy glaucoma, intestinal obstructive or motility disease, obstructive uropathy, myasthenia gravis, BPH, neurological or psychiatric conditions, Sjögren's or Sicca syndrome, or cardiac abnormalities that may alter or exacerbate sweat production by the use of anticholinergics in the investigator's opinion.
- Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of the components of the topical formulation.
- Subject is pregnant, lactating or is planning to become pregnant during the study.
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Westlake Dermatology & Cosmetic Surgery
Austin, Texas, 78746
Delricht Research
Baton Rouge, Louisiana, 70809
Bellaire Dermatology Associates
Bellaire, Texas, 77401
Cahaba Dermatology Skin & Health Center
Birmingham, Alabama, 35244
CoDerm Research
Centennial, Colorado, 80111
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
DeNova Research
Chicago, Illinois, 60611
Michigan Center for Skin Care Research
Clinton Township, Michigan, 48038
J&S Studies, Inc.
College Station, Texas, 77845
Driven Research, LLC
Coral Gables, Florida, 33134
Florida Academic Dermatology Centers Research & Education, LLC
Coral Gables, Florida, 33134
CCD Research, PLLC
Cromwell, Connecticut, 06416
Modern Research Associates
Dallas, Texas, 75231
Colorado Medical Research Center
Denver, Colorado, 80210
Aventiv Research Inc.
Dublin, Ohio, 43016
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
Qualmedica Research, LLC
Evansville, Indiana, 47715
Hamzavi Dermatology, Inc.
Fort Gratiot, Michigan, 48059
First OC Dermatology
Fountain Valley, California, 92708
Advanced Research Associates
Glendale, Arizona, 85308
University of Texas Health Science Center at Houston
Houston, Texas, 77030
Suzanne Bruce and Associates, P.A.
Houston, Texas, 77056
JDR Dermatology Research
Las Vegas, Nevada, 89148
GSI Clinical Research
Margate, Florida, 33063
Cordova Research Institute
Miami, Florida, 33155
Yardley Dermatology Associates, PC
Morrisville, Pennsylvania, 19067
DelRicht Research
New Orleans, Louisiana, 70116
Lupo Center for Aesthetic and General Dermatology
New Orleans, Louisiana, 70124
Etre, Cosmetic Dermatology and Laser Center
New Orleans, Louisiana, 70130
Arkansas Research Trials
North Little Rock, Arkansas, 72117
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
SkinSearch of Rochester
Rochester, New York, 14623
DermAssociates
Rockville, Maryland, 20850
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, 78229
Advanced Medical Research PC
Sandy Springs, Georgia, 30328
Valley Dermatology and Skin Cancer Center
Spokane, Washington, 99216
Saint Louis University, Department of Dermatology
St Louis, Missouri, 63122
MOORE Clinical Research, Inc.
Tampa, Florida, 33609
The GW Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472
Center for Clinical Studies, LTD.LLP
Webster, Texas, 77598
Heartland Research Asssociates - AMR Company
Wichita, Kansas, 67205
About this study
Official title: A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 15% in Subjects With Axillary Hyperhidrosis
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands.
Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis.
This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.
Read the detailed description
This is a multicenter, randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of topically applied sofpironium bromide, 15% gel in subjects with axillary hyperhidrosis.
Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology, serum chemistry laboratory testing and urinalysis.
A maximum of 350 subjects will be randomized to receive either sofpironium bromide gel, 15% or vehicle.
Adverse events, vital signs, and local tolerability assessments will be collected at visits across the study. Urine pregnancy tests will be taken throughout the course of the study for women of child bearing potential. Blood and urine samples will be collected and analyzed for routine hematology, chemistry, and urinalysis parameters at specified visits. Patient-reported outcome assessments will be recorded during the study at predefined time points.
The study will be comprised of a total of 13 scheduled visits to take place over approximately 11 to 15 weeks.
- Conditions
- Axillary Hyperhidrosis
- Being tested
- Sofpironium Bromide, 15%, Vehicle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofpironium Bromide, 15%Drug
Also called BBI-4000, 15%
Active
VehicleDrug
Also called BBI-4000, 0%
Vehicle gel
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Sofpironium bromide, 15% gel, once per day Receives: Drug: Sofpironium Bromide, 15% |
| Vehicle | Placebo comparator | Vehicle gel, once per day Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants (Vehicle Arm vs. Sofpironium Bromide Gel, 15%) With and Without an Observed ≥2-point Improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score From Baseline to End of Treatment
Change in score from baseline to end of treatment of 7 questions from the patient reported outcome assessment - Hyperhidrosis Disease Severity Measure-Axillary-7; each question had a 5-point response (range 0 [better] - 4 [worse]). Total scores were calculated by averaging the score of all items, resulting in an axillary hyperhidrosis symptom range of 0 (no sweating) to 4 (worst possible sweating). Improvement corresponded to a ≥2-point reduction of individual participant score from baseline to end of treatment (end of treatment [6 weeks] score minus baseline score). Treatment arms compared included vehicle and Sofpironium Bromide Gel, 15%. Counts of participants (per treatment arm) with and without an observed ≥2-point improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score from baseline to end of treatment were used as the outcome value(s).
Measured: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.
Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment
Individual gravimetric sweat production values were reported as the combined measured weight (mg) of axillary (right +left axillae) sweat production at each visit. Gravimetric sweat production values were rank-transformed.
Baseline GSP was the median rank of GSP measurements obtained on Visit 2, Visit 3, and Visit 4.
End of Treatment GSP was the median rank of GSP measurements obtained on Visit 10, Visit 11, and Visit 12.
The difference in ranked GSP from baseline to end of treatment (ranked GSP at end of treatment [6 weeks] minus ranked GSP at baseline) was used as the outcome value.
Measured: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start4 Dec 2020
- Primary completion13 Aug 2021
- Study completion13 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Axillary HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Botanix Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patricia Walker, MD PhD, Study director, Botanix Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948646
- Sponsor's protocol ID
- BBI-4000-CL-302
- Acronym
- CARDIGANII
- Status last verified
- May 2024
- First submitted
- 10 May 2019
- Last updated
- 21 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 15% in Subjects With Axillary Hyperhidrosis
- ClinicalTrials.gov ID
- NCT03948646
- Acronym / sponsor ID
- CARDIGANII / BBI-4000-CL-302
- Conditions
- Axillary Hyperhidrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Botanix PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2020 (actual)
- Primary completion
- 13 Aug 2021 (actual)
- Study completion
- 13 Aug 2021 (actual)
- First posted
- 14 May 2019 (actual)
- Results
- Posted 21 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands.
Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis.
This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.
Detailed description
This is a multicenter, randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of topically applied sofpironium bromide, 15% gel in subjects with axillary hyperhidrosis.
Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology, serum chemistry laboratory testing and urinalysis.
A maximum of 350 subjects will be randomized to receive either sofpironium bromide gel, 15% or vehicle.
Adverse events, vital signs, and local tolerability assessments will be collected at visits across the study. Urine pregnancy tests will be taken throughout the course of the study for women of child bearing potential. Blood and urine samples will be collected and analyzed for routine hematology, chemistry, and urinalysis parameters at specified visits. Patient-reported outcome assessments will be recorded during the study at predefined time points.
The study will be comprised of a total of 13 scheduled visits to take place over approximately 11 to 15 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Sofpironium Bromide, 15%Sofpironium bromide, 15% gel, once per day |
| Vehicle | Placebo comparator | Drug: VehicleVehicle gel, once per day |
Who may qualify
- Ages
- 9 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subject ≥ 9 years of age.
- Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhidrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4 and (c) a minimum GSP of 50 mg in each axilla with a combined total of at least 150 mg.
- The ability to understand and follow all study-related procedures including study drug administration.
- Sexually active female of childbearing potential (FOCBP)* must agree to periodic pregnancy testing and use a medically acceptable method of contraception while receiving protocol-assigned product.
Key exclusion criteria (8 listed)
- In the Investigators opinion, any skin or subcutaneous tissue conditions of the axilla(e).
- Prior use of any prohibited medication(s) or procedure(s) within the specified timeframe for the treatment of axillary hyperhidrosis.
- Anticholinergic agents used to treat conditions such as, but not limited to, hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by any route of administration.
- Use of any cholinergic drug (e.g. bethanechol) within 28 days.
- Known cause of hyperhidrosis or known history of a condition that may cause hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism, diabetes mellitus, medications, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofpironium Bromide, 15%Also: BBI-4000, 15%Active | Drug | Active |
| VehicleAlso: BBI-4000, 0%Vehicle gel | Drug | Vehicle |
Primary outcome
Number of Participants (Vehicle Arm vs. Sofpironium Bromide Gel, 15%) With and Without an Observed ≥2-point Improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score From Baseline to End of Treatment
Time frame: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.
Change in score from baseline to end of treatment of 7 questions from the patient reported outcome assessment - Hyperhidrosis Disease Severity Measure-Axillary-7; each question had a 5-point response (range 0 [better] - 4 [worse]). Total scores were calculated by averaging the score of all items, resulting in an axillary hyperhidrosis symptom range of 0 (no sweating) to 4 (worst possible sweating). Improvement corresponded to a ≥2-point reduction of individual participant score from baseline to end of treatment (end of treatment [6 weeks] score minus baseline score). Treatment arms compared included vehicle and Sofpironium Bromide Gel, 15%. Counts of participants (per treatment arm) with and without an observed ≥2-point improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score from baseline to end of treatment were used as the outcome value(s).
Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment
Time frame: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.
Individual gravimetric sweat production values were reported as the combined measured weight (mg) of axillary (right +left axillae) sweat production at each visit. Gravimetric sweat production values were rank-transformed. Baseline GSP was the median rank of GSP measurements obtained on Visit 2, Visit 3, and Visit 4. End of Treatment GSP was the median rank of GSP measurements obtained on Visit 10, Visit 11, and Visit 12. The difference in ranked GSP from baseline to end of treatment (ranked GSP at end of treatment [6 weeks] minus ranked GSP at baseline) was used as the outcome value.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Walker, MD PhD study director
Botanix Pharmaceuticals
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sofpironium Bromide, 15% in people with Axillary Hyperhidrosis, run by Botanix Pharmaceuticals at 42 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants (Vehicle Arm vs. Sofpironium Bromide Gel, 15%) With and Without an Observed ≥2-point Improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score From Baseline to End of Treatment (time frame: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.